Trials / Completed
CompletedNCT03895996
Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes
A Phase 1 / 2 Double-Blind, Randomized, Placebo Controlled Study of Safety, Tolerability and Potential Efficacy of AVOTRES Cell-Based Therapy (AVT001) in Patients With Type 1 Diabetes
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Avotres Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AVT001 | autologous dendritic cell therapy |
| OTHER | Placebo | matched placebo |
Timeline
- Start date
- 2019-06-20
- Primary completion
- 2022-05-17
- Completion
- 2023-12-19
- First posted
- 2019-03-29
- Last updated
- 2025-03-05
- Results posted
- 2025-03-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03895996. Inclusion in this directory is not an endorsement.